Clinical Trials Logo

Filter by:
NCT ID: NCT03839342 Active, not recruiting - Solid Tumor Clinical Trials

Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations

BEAVER
Start date: June 7, 2019
Phase: Phase 2
Study type: Interventional

This is a single-centre, open-label Phase II study of the investigational drugs binimetinib and encorafenib that will be taken my mouth (orally) daily in adult patient with advanced and/or metastatic solid tumors for which no other standard therapy is available. The main purpose is to evaluate the objective response rate (ORR) of the study drugs in the growth of the cancer in patients with class 2 and 3 BRAF mutations.

NCT ID: NCT03838783 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered

FIT Untethered
Start date: May 15, 2018
Phase: Phase 4
Study type: Interventional

The overall objective of this study is to evaluate glycemic control and patient-reported outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous subcutaneous insulin infusion in a combination untethered regimen during moderate or high-intensity exercise.

NCT ID: NCT03838718 Recruiting - Clinical trials for Retroperitoneal Sarcoma

REtroperitoneal SArcoma Registry: an International Prospective Initiative

RESAR
Start date: September 1, 2016
Phase:
Study type: Observational [Patient Registry]

Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority. Primary Objectives of this study are: - to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers. - patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM). Secondary Objectives: - to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS; - to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy; - to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease; - to utilize collected pathological material for research collaborations.

NCT ID: NCT03838601 Active, not recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2

ROMA LA-OPSCC2
Start date: July 2, 2019
Phase: N/A
Study type: Interventional

This is a single-centre feasibility study designed to assess the safety, tolerability and engraftment of MET-4 bacterial strains when given in combination with chemoradiotherapy (CRT). The study will involve a prospective cohort of 30 patients diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) to be treated with CRT as per standard of care at Princess Margaret Cancer Centre. All patients enrolled will receive MET-4 in addition to standard CRT. MET-4 is administered orally as an initial daily loading dose over 2 days followed by a daily maintenance dose of MET-4 and will be administered until week 4 of CRT or unacceptable toxicity whichever occurs earlier and in the absence of criteria to discontinue MET-4. This protocol does not determine eligibility to receive treatment with concurrent CRT. It is anticipated that patient accrual will be completed within 12 months.

NCT ID: NCT03838445 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

RELIEVE-PAH
Start date: February 14, 2020
Phase: N/A
Study type: Interventional

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

NCT ID: NCT03837132 Completed - Advanced Cancer Clinical Trials

Early Palliative Care on Quality of Life of Patients With Advanced Pancreas Cancer

Start date: October 15, 2018
Phase:
Study type: Observational

The primary objective is to explore the impact of early palliative care on quality of life in patients with advanced pancreatic cancer. The secondary objectives are to explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer.

NCT ID: NCT03837106 Completed - Clinical trials for Musculoskeletal Disorder

Workplace Rehabilitation for Musicians: Program Optimisation and Evaluation

Start date: February 18, 2019
Phase: N/A
Study type: Interventional

Background: The classical musician's work, which comprises numerous daily hours of precise and often strenuous repetitive movements in asymmetrical postures, renders them vulnerable to musculoskeletal (MSK) injury. Performance-related MSK disorders (PRMDs) have been defined as "any pain, weakness, numbness, tingling or other physical symptoms that interfere with your ability to play your instrument at the level to which you are accustomed". The lifetime prevalence of PRMDs in professional instrumental musicians ranges from 62 to 93%. Furthermore, typical musical instruction does not include education on physical health and injury prevention, and this is thought to be an important factor in musicians' development of pain and injuries. The combination of musician-specific exercise and education on injury prevention may have greater impacts on musicians' wellbeing than exercise or education alone. In a pilot trial, 15 orchestral musicians were offered an educational presentation and carried out a home exercise program for 11 weeks. There were no dropouts, exercise adherence was high and musicians reported improvement of their symptoms. However, certain weaknesses were identified. Thus, this type of rehabilitation program demonstrates much potential for improving the wellbeing of orchestral musicians, but improvements should be made. The collaboration of experts with relevant backgrounds, including musicians who were exposed to the program, can optimize the program. Objectives and hypotheses: The objectives are 1) to identify facilitators and obstacles to the implementation of the initial program by realizing focus groups with musicians; 2) to adapt the program to the local context; 3) to evaluate the effectiveness of the revised program to decrease the intensity, functional impact and frequency of PRMDs in musicians with a pilot randomised controlled trial (RCT); 4) to evaluate the effect of the educational components of the program on health-related knowledge and behaviour. The hypothesis for objective 3 is that a decrease in PRMD intensity, frequency and functional limitations will be demonstrated in the experimental group following participation in the program, compared to the control group. Methods: 1. - Focus groups: The 15 pilot project participants will be invited to share their perceptions regarding the initial program. Sessions will be comprised of questions on implementation determinants described in the Consolidated Framework for Implementation Research. 2. - Adaptation to local context: Experts in education and exercise will design the components of the program according to results from Step 1. All new or modified exercises will be reviewed by two clinicians, and tried by participants from the pilot trial. New comments will be considered, and an adapted program will be proposed. 3. - Implementation and evaluation of effectiveness Participants: Fifty orchestral musicians (25 per group) will be recruited from full and part-time orchestras and university-level music performance programs. Students will be included because the program will have the potential to directly impact the workers of tomorrow. Musicians with and without PRMDs will be invited to participate, as the program is both preventive and curative. Study design: Pilot single-blind RCT with 1-year follow-up. Participants will be evaluated at baseline (T0), at the end of the 3-month rehabilitation program (T1) and 1 year later (T2). The baseline evaluation will consist of questionnaires on PRMD symptoms and functional limitations. Following baseline, subjects will be randomly assigned to either a rehabilitation program (exercise group) or no intervention (control group). Randomization will be stratified by instrument group and PRMD prevalence (presence or absence of symptoms). The same questionnaires will be completed by all participants at evaluations 2 and 3. All meetings will be held in participants' workplace. Intervention: The rehabilitation program will consist of education on healthy practice habits and load and injury management and a 3-month home exercise program specific to musicians. Control group members will receive no intervention until after T2. Baseline demographics will be compared between groups (independent t-tests, chi-square tests). Two-way mixed-model analyses of variance (ANOVA) will explore the effect of the rehabilitation program on PRMD symptoms and functional limitations. Relevance: Orchestral musicians frequently suffer from debilitating pain that can have a lasting impact on their career. Our multi-sectorial research and clinical team hopes to create an effective rehabilitation program that can be offered to many musical populations. If the program is effective, next steps will include integration of the program into the workplace. In order to have longer-lasting and further-reaching impacts on musicians' wellbeing, the presence of rehabilitation in the workplace is the ultimate goal.

NCT ID: NCT03837015 Completed - HIV-1-infection Clinical Trials

Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women

Start date: November 4, 2019
Phase: Phase 1
Study type: Interventional

This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.

NCT ID: NCT03836885 Withdrawn - Oral Lichen Planus Clinical Trials

Apremilast - Oral Lichen Planus Trial

APOLP
Start date: November 21, 2019
Phase: Phase 2
Study type: Interventional

Apremilast for the management of oral lichen planus.

NCT ID: NCT03836716 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

Start date: September 19, 2019
Phase: Phase 3
Study type: Interventional

A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS) who have completed the ORARIALS-01 trial.